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510(k) Data Aggregation

    K Number
    K202955
    Device Name
    Contour Light CL-100
    Manufacturer
    Contour Research, LLC
    Date Cleared
    2021-05-19

    (231 days)

    Product Code
    OLI
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Contour Research, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Contour Light CL-100 device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The Contour Light CL-100 device is indicated to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle spasm, and pain and stiffness associated with arthritis, for promoting relaxation of the muscle tissue, and to temporarily increase local blood circulation.
    Device Description
    The Contour Light CL-100 is a low level laser (red light LED) system that applies 635nm light for the purpose of reducing the circumference of the hips, waist and thighs for aesthetic benefit, and 630nm light for the purpose of temporarily elevating skin temperature. The Contour Research, LLC Contour Light CL-100 device applies a light emitting diode (LED) technology, and is used to perform red light LED-based circumferential reduction of the hips, thighs and waist in adults, or red light and IR LEDs for temporary elevation of skin temperature, within a treatment time of 30 minutes. The device is comprised of a panel of LEDs that is adjustable to conform generally to the outer dimensions of the individual being treated, a software controlled console that is used to select and maintain the application of the LED light, a power adaptor, and cables that connect to the energy source. The device is powered by connecting it to an 85-264 VAC, at 3 amps, 47-63 Hz. power source.
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